UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007270 |
|---|---|
| Receipt number | R000008577 |
| Scientific Title | Preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity in patients with breast cancer |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2012/02/12 18:08:19 |
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Basic information
Public title
Preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity in patients with breast cancer
Acronym
Preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity in patients with breast cancer
Scientific Title
Preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity in patients with breast cancer
Scientific Title:Acronym
Preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity in patients with breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of paclitaxel -induced peripheral neurotoxicity and preventive effect of frozen glove for paclitaxel -induced peripheral neurotoxicity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Breast cancer patient who receiving paclitaxel
2) written informed consent
Key exclusion criteria
patients untolerable for cooling
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suzuki Sachi |
Organization
Wakayama Medical University Kihoku Hospital
Division name
Nursing Department
Zip code
Address
649-7113 279 Myoji, Kasturagicho, Ito, Wakayama, Japan
TEL
0736-22-0066
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suzuki Sachi |
Organization
Wakayama Medical University Kihoku Hospital
Division name
Nursing Department
Zip code
Address
TEL
Homepage URL
yuzu-soushi2518@hb.tp1.jp
Sponsor or person
Institute
Wakayama Medical University Kihoku Hospital
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University Kihoku Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2012 | Year | 02 | Month | 12 | Day |
Last modified on
| 2012 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
